Clinical Research Directory

SAFE-iPS - France's First Hospital-based Platform for the Production of Induced Pluripotent Stem Cells for the Regenerative Medicine of the Future

The objective of the study is to establish the first French hospital-based Good Manufacturing Practice (GMP)-compliant platform for the production of clinical-grade induced pluripotent stem cells (iPSCs) for future regenerative medicine applications. The primary objective is to generate, via the SAFE-iPS platform, 4 clinical-grade iPSC lines derived from peripheral blood samples taken from: * Two healthy male volunteers * Two healthy female volunteers These 4 iPSC lines will undergo comprehensive quality assessment including: * Expression of pluripotency markers * Genomic stability assessment * Absence of residual Sendai viral integration * Technical reproducibility assessment * Manufacturing efficiency assessment * Preliminary medico-economic evaluation This project aims to demonstrate that the SAFE-iPS manufacturing process can be successfully transferred to a hospital Good Manufacturing Practice (GMP) environment and can reproducibly generate clinical-grade iPSC lines meeting international quality standards for future regenerative medicine applications. It also aims to establish the first French public hospital platform dedicated to routine GMP production of clinical-grade iPSCs.

RESTOREGI Study: Regenerative Endoscopic Stromal Therapy: Outcomes and Risk Factor Evaluation in GI Fistulas

RESTOREGI Study Benign gastrointestinal fistulas are abnormal communications between the gastrointestinal tract and adjacent organs or the skin. Chronic fistulas are often difficult to treat because of persistent inflammation, fibrosis, impaired vascularity, and defective tissue regeneration. Endoscopic regenerative therapy using mechanically processed autologous total stromal vascular fraction-enriched microfragmented adipose tissue (tSVF-EM) has emerged as a novel therapeutic approach that may promote tissue repair through angiogenesis, immunomodulation, and regenerative signaling. Although early clinical experience suggests promising healing outcomes, factors predicting successful fistula closure remain poorly understood. The RESTOREGI study is a prospective, single-center observational cohort study designed to identify patient-related, fistula-related, and procedural factors associated with successful healing following endoscopic tSVF-EM therapy in benign gastrointestinal fistulas. The study will also evaluate treatment safety, time to healing, recurrence rates, and the impact of procedural variables on outcomes.